Entropy secures GMP manufacturing partner for IV-psilocin therapy TRP-8803
Entropy Neurodynamics (ASX: ENP) has executed a Development and Manufacturing Services Agreement with BioCina to GMP manufacture its proprietary TRP-8803, an intravenous-infused psilocin formulation. The agreement establishes the manufacturing foundation for the broader international development and commercialisation of TRP-8803.
BioCina is a Contract Development and Manufacturing Organisation (CDMO) that is TGA-licensed, FDA-inspected and EMA-aligned. The partnership positions TRP-8803 for progression into international Phase 2/3 trials, according to the Company.
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Why the BioCina agreement matters
Establishing a robust and scalable manufacturing process is a critical component of Entropy’s Phase 2/3 trial and commercialisation strategy. BioCina brings an end-to-end CDMO capability spanning drug substance and drug product, from clinical development through to commercial supply.
Importantly for this therapeutic class, BioCina holds an active TGA license for Schedule 8 controlled substances and maintains the regulatory framework required to handle Schedule 9 active pharmaceutical ingredients (APIs), including psilocin. That licensing profile is a critical enabler for a psychedelic drug programme.
The CDMO’s credentials position it to de-risk the pathway toward major international markets:
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End-to-end CDMO across drug substance and drug product, from clinical development through to commercial supply
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Active TGA license for Schedule 8; regulatory framework for Schedule 9 APIs, including psilocin
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Track record of FDA inspections and EMA-aligned quality systems
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More than 225 million sterile units manufactured annually
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Supplies products to more than 100 countries from facilities in Perth and Adelaide
BioCina CEO, Dr Thomas Broudy
“We are pleased to partner with Entropy Neurodynamics on the TRP-8803 program. BioCina has significant experience supporting innovative pharmaceutical products through clinical development and commercialisation, backed by established sterile manufacturing infrastructure and global supply capabilities. We look forward to working with Entropy to establish a scalable manufacturing process capable of supporting the continued development of TRP-8803.”
What is TRP-8803 and why IV-psilocin matters
TRP-8803 is Entropy’s proprietary intravenous-infused psilocin formulation. Psilocin is the active metabolite of psilocybin, the compound most commonly associated with psychedelic therapy research.
The formulation is designed to overcome the variability and unpredictability of oral psilocybin. By delivering the compound intravenously, the treatment enables consistent therapeutic exposure with precise control over the onset, intensity and duration of the psychedelic experience.
Why does this matter to investors? A reproducible treatment profile is what makes large-scale clinical deployment and commercialisation feasible. According to the Company, the IV approach offers several potential advantages:
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Significantly reduces the time to onset of the psychedelic state
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Controls the depth and duration of the experience
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Reduces the overall intervention to a commercially feasible timeframe
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Delivers a reproducible profile suitable for large-scale deployment
Inside the manufacturing programme
Under the Agreement, BioCina will undertake a comprehensive programme encompassing analytical verification, engineering batch manufacture, followed by GMP placebo and active drug product batches.
The pharmaceutical and stability data generated will form a core component of Entropy’s regulatory submissions in the United States, Europe and other major markets, supporting progression into late-stage clinical development.
TRP-8803 will be GMP manufactured at BioCina’s Perth facility using its Cytiva SA25 robotic aseptic filling line, with the product filled into sterile 10 mL glass vials. Under the Agreement, Entropy retains full ownership of all TRP-8803 IP and product-specific know-how.
The manufacturing infrastructure being locked in through the BioCina agreement sits alongside a recently granted psilocin crystalline forms patent, which provides composition-of-matter protection over the molecular core of TRP-8803 until September 2043 and directly underpins the IP that Entropy retains under this agreement.
| Element | Detail | Investor relevance |
|---|---|---|
| Facility | BioCina Perth | TGA-licensed, FDA-inspected site |
| Filling line | Cytiva SA25 robotic aseptic line, sterile 10 mL glass vials | Commercial-grade consistency |
| Programme duration | 24 weeks | Near-term data catalyst |
| Stability studies | Real-time, continuing for 24 months | Supports regulatory submissions |
| IP ownership | Retained fully by Entropy | Shareholder value preserved |
How this fits the broader clinical programme
The Agreement supports Entropy’s expanding clinical programme, which includes a recently approved 72-patient study evaluating TRP-8803 across eight neuropsychiatric indications of high-unmet clinical need (refer ASX announcement: 4 August 2026).
The manufacturing capacity being established is designed to be leveraged across Entropy’s full TRP-8803 development, rather than being limited to any single clinical study or indication. According to the Company, establishing a robust and scalable manufacturing process is a critical component of its Phase 2/3 trial and commercialisation strategy.
The manufacturing capacity being established through BioCina is designed to serve Entropy’s full development pipeline, including the recently approved 72-patient basket trial targeting eight neuropsychiatric indications simultaneously, a capital-efficient structure estimated to cost just A$3.2 million.
CEO, Mr Jason Carroll
“Our agreement with BioCina is an important strategic step in building the infrastructure required to realise the broader potential of TRP-8803. We are generating an expanding body of clinical evidence around our precision-controlled IV approach to psychedelic therapy and, as that program develops, it is important that we build the pharmaceutical manufacturing capability alongside it. As our multi-indication development strategy advances, this agreement with BioCina ensures that as our clinical evidence base expands, TRP-8803 is supported by a manufacturing engine capable of rapid scale-up, global distribution and commercial-grade consistency.”
What comes next for Entropy
With scalable GMP manufacturing now in place, Entropy is positioned to advance TRP-8803 across multiple indications, multiple geographies and multiple regulatory pathways. The 24-week manufacturing programme and the 24-month real-time stability studies represent the key near-term milestones ahead.
Key milestones ahead include:
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Completion of the 24-week manufacturing programme
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Ongoing 24-month real-time stability studies
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Progression toward international Phase 2/3 trials
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Regulatory submissions across the United States, Europe and other major markets
Ready to Learn More About the TRP-8803 Development Programme?
Entropy Neurodynamics has secured a critical GMP manufacturing partner in BioCina, establishing the scalable infrastructure needed to advance its proprietary IV-psilocin formulation across multiple indications and international regulatory pathways. With a 72-patient basket trial underway and a patent protecting TRP-8803’s molecular core until 2043, the commercial foundation is taking shape.
Explore the full pipeline, clinical strategy, and investment case by visiting the Entropy Neurodynamics investor centre. Stay ahead of the key milestones as TRP-8803 progresses toward international Phase 2/3 trials and regulatory submissions across the United States, Europe, and beyond.